Kornimate/medical-research-clean huggingface dataset:
pharmaco-immunological study of interferon-alpha and metronomic cyclophosphamide association in neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: this study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (cmc) and interferon-alpha (ifn-alpha).


Eligibility criteria:
inclusion criteria: * performance status ecog-who ≤ 1 * histologically proved neuroendocrine tumor with ki67 \< or = 10%, metastatic or locally advanced without surgery possibility * at least one measurable lesion based on recist criteria version 1.1 * signed written informed consent exclusion criteria: * previous treatment with interferon or cyclophosphamide * treatment by immunosuppressive drugs * diabetes complicated by coronary artery disease or vasculopathy * severe respiratory failure, chronic respiratory failure, copd * history of severe heart failure * severe renal or hepatic impairment * diabetes complicated with coronary artery disease or vasculopathy * alcoholism unweaned * uncontrolled epilepsy and/or achievement of the central nervous system functions * history of severe depressive syndrome * presence or history of severe psychiatric condition, particularly severe depression, suicidal thoughts or attempted suicide * decompensated liver cirrhosis * severe myelosuppression * psoriasis and sarcoidosis * active disease condition or uncontrolled infection * association with the yellow fever vaccine * association with phenytoin in prophylaxis * hypersensitivity against interferon or cyclophosphamide * prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 3 years * pregnancy, breast-feeding or absence of adequate contraception for fertile patients * patients under guardianship, curatorship or under the protection of justice
bioequivalency study of morphine sulfate injection, solution and tablet under fasted conditions

Conditions: Pain

Summary: determine the pharmacokinetics and optimize study design for subsequent studies with morphine sulfate tablets and solution.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to morphine sulfate or any comparable or similar product.
study of vx-770 on desipramine

Conditions: In Development for Cystic Fibrosis

Summary: the objective of this study is to evaluate the effects of vx-770 on desipramine


Eligibility criteria:
inclusion criteria: * subjects must be male or female and between 18 and 55 years of age * subject must have a body mass index (bmi) from 18 to 30 kg/m2 * subject must be judged to be in good health exclusion criteria: * history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject * subjects who have human immunodeficiency virus, hepatitis c, or active hepatitis b * female subjects and male subjects with female partner(s) who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
prospective follow-up of outcomes in patients receiving photodynamic therapy for neoplastic diseases

Conditions: Neoplastic Disease

Summary: from 1996-present, we have used photodynamic therapy (pdt) to treat a number of neoplastic diseases both on prospective research protocols (for head and neck cancer, pleural malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for fda approved and off label or compassionate exemption indications (neoplasms of the skin, bronchus, esophagus, head and neck and pleura). the goal of this treatment is to maximize quality of life and organ function while minimizing the chance of tumor recurrence. as such, we would like to retrospectively review the treatment parameters of all patients who undergo/underwent pdt (including operative notes and photodynamic therapy records) and treatment outcomes (including all organ functions, performance status, tumor recurrence, laboratory values and any other data present in the routinely documented follow up visits). for patients who have died or were lost to follow-up prior to initiation of this study, a retrospective review of available data will be performed. for patients who are still being actively followed after pdt or who receive pdt after the initiation of this study, informed consent will be obtained for obtaining continued follow-up data prospectively and any previous data will be collected retrospectively.. these subjects will continue to receive care from their current physicians according to standard medical practice and no attempt will be made to alter the types of follow-up, radiologic or other diagnostic studies or medical treatment as a result of enrollment in this study. all data will be de-identified and added to our already existing pdt treatment outcome databases for outcomes analysis, quality improvement and reporting of results in abstract and manuscript forms.


Eligibility criteria:
inclusion criteria: * subjects will be age 18 or greater * subjects will have undergone pdt for a diagnosis of neoplastic disease under the direction of a penn physician. exclusion criteria: * none

Keywords: adult subjects history treatment photodynamic therapy
randomized study in children and adolescents with migraine: acute treatment

Conditions: Pediatric Migraine

Summary: the purpose of this study is to test the safety and efficacy of bhv-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.


Eligibility criteria:
inclusion criteria: 1. history of migraine (with or without aura) for \> 6 months before screening according to the ihs classification ichd-319 specifications for pediatric migraine. history may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s). 2. history of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours. 3. prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the baseline visit, and the dose is not expected to change during the course of the study. 1. participants may remain on one (1) medication with possible migraine prophylactic effects, excluding cgrp antagonists \[biologic or small molecule\], during the treatment phases. 2. concomitant use of a cgrp antagonist, such as erenumab or fremanezumab, is prohibited. 3. previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the screening visit. 4. verbally distinguish between migraine and other types of headaches. 5. participants must have a weight \> 40 kg at the screening visit. 6. adequate venous access for blood sampling. 7. male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study). exclusion criteria: 1. history of cluster headache or hemiplegic migraine headache. 2. confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study. 3. current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the screening visit. participants with a lifetime history of psychosis and/or mania. 4. history of suicidal behavior or major psychiatric disorder. 5. current diagnosis or history of substance abuse; positive drug test at screening. 6. history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning. 7. recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the screening visit. 8. participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding). 9. current diagnosis of viral hepatitis or a history of liver disease. 10. conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Keywords: migraine acute treatment phonophobia photophobia nausea pediatric children adolescent pediatric migraine
basic and clinical research on attention deficit hyperactivity disorder (adhd)

Conditions: ADHD

Summary: children between 6-17 are evaluated for adhd and and a blood sample is obtained for dna extraction. if eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. in randomized order, children receive 18, 36, 54 mg. oros methylphenidate and placebo. each week, parent report measures, clinical interviews, and safety assessments are conducted. hypothesis: efficacy and adverse events will be dose dependent. dopamine transporter genotype will predict response


Eligibility criteria:
inclusion criteria: * 6-17 dsm iv criteria for adhd parents willing to complete measures exclusion criteria: * mental retardation psychoses seizure disorder

Keywords: adhd side effects sleep dopamine pharmacogenetics
metacognitive therapy versus cognitive behavioral therapy for mixed anxiety disorders: a randomized controlled trial.

Conditions: Mixed Anxiety Disorders

Summary: comorbidity is normal in clinical practice. metacognitive therapy (mct) is a transdiagnostic model and could therefore be well suited when it comes to treating patients with high rates of comorbidity. so far, no studies have examined mct in comparison with the best documented and evidence based treatment, cognitive behavioral treatment(cbt), in a randomized controlled trial consisting of mixed anxiety disorder sample with high degree of comorbidity. the main aim of this study is to 1) evaluate the effectiveness of metacognitive therapy in a sample of mixed anxiety disorders as compared to a group receiving existing evidence-based single diagnosis cbt- treatment protocols 2) investigate patterns and mechanisms of change in the two treatments.


Eligibility criteria:
inclusion criteria: * dsm iv diagnoses of sad, pd/a or ptsd (csr\>4) * withdraw of all psychotropic medications before treatment exclusion criteria: * psychosis * not willing to accept randomization * comorbid conditions are in immediate need of treatment

Keywords: mct metacognitive therapy anxiety disorders transdiagnostic
radiotherapy treatments for neoplasms in the head and neck region

Conditions: Head and Neck Neoplasms

Summary: the aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region. eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region.

approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment. various primary tumors as well as metastases of various origins can be localized in the head and neck anatomical region. patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments. treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects. the collection of data related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. the availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies. this project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms of the head and neck region for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Eligibility criteria:
inclusion criteria: * patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the head and neck region include those with: * primary bone tumors, * primary soft tissue tumors, * primary tumors of the cardio-circulatory system, * primary tumors of the lymphatic system, * primary tumors of the nervous system and skin, * secondary metastases from various origins localized in that district. * signed informed consent exclusion criteria: • radiotherapy in districts other than the head and neck region
impact of active heating on maternal and neonatal well-being

Conditions: Hypothermia

Summary: this study was conducted to determine the effects of actively warming the patient and using warmed intravenous (iv) fluid during cesarean section on maternal and infant well-being

this study was conducted to determine the effects of actively warming the patient and using warmed intravenous (iv) fluid during cesarean section on maternal and infant well-being. the study was conducted in a university hospital with a total of 105 women who gave birth by cesarean section randomly selected from 35 intervention 1 (only underbody heater group), 35 intervention 2 (both underbody heater and heated iv fluid group) and 35 control group. the research data were collected with the individual information form, patient follow-up form and visual analog scale. apgar score, body temperature, cortisol and glucose levels were evaluated in the infant and body temperature, intraoperative bleeding, shivering, postoperative pain, gas and urination were evaluated in the mother between the three groups. descriptive statistics, chi-square, shapiro wilks, friedman, wilxocon, kuruskal wallis and mann whitney u test were used in the evaluation of the data and significance level p\<0.05 was accepted.

Eligibility criteria:
inclusion criteria: * elective cesarean section with spinal anesthesia, * 37 weeks of gestation and above, * with asa i and asa ii scores, * pregnant women with a healthy fetus, * the preoperative fasting period is between 2 to 12 hours, * pregnant women who were normothermic (36 to 37.5°c) preoperatively exclusion criteria: * those requiring emergency delivery or with comorbidities * multiple pregnancies, * anemic pregnant women with a hemoglobin value below 11 g/dl according to the world health organization (2001), * central body temperature above 37.5°c and below 36°c on the morning of surgery * pregnant women with a history of malnutrition, thyroid function and other endocrine disorders, parkinson's disease, peripheral circulatory disorders, diabetes mellitus, heart disease and stroke, * pregnant women with chronic bowel problems and urinary system problems were not included in the study.
efficacy and safety of bf2.649 in excessive daytime sleepiness (eds) in parkinson's disease

Conditions: Parkinson's Disease

Summary: to compare the efficacy of bf2.649 over placebo (12 week double-blind phase) and assess the long term safety and the efficacy maintenance(9 months open-label extension phase) of bf2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with parkinson's disease.

as measured by the change from baseline in the epworth scale scores (ess) at week 12 and at week 51, in patients diagnosed with eds in parkinson's disease.

Eligibility criteria:
inclusion criteria: * patients with a documented history of parkinson's disease according to updrs,fluctuator and non-fluctuator patients, hoehn and yahr score \<5; * stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry; * presenting an excessive daytime sleepiness as indicated by an ess\>or=12 exclusion criteria: * patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse lewy's body dementia) * patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders * patients with a severe depression indicated by (bdi\>= 16)or at suicidal risk (bdi item g\>0) or depression treated for less than 8 weeks * patients with a cognitive impairment

Keywords: excessive daytime sleepiness (eds) parkinson's disease
preventing brain injury in infants with congenital heart disease

Conditions: Cyanotic Congenital Heart Disease

Summary: newborn babies with congenital heart disease often require surgery in the first month of life. the risks of brain damage from congenital heart disease and from the various corrective surgeries are high because of poor levels of oxygen reaching the brain. topiramate is an anti-convulsant medication that protects brain cells from damage due to low amounts of oxygen in animal studies. the investigators hypothesize that giving topiramate to babies with congenital heart disease before and after surgery will decrease the amount of brain damage caused by the heart disease and/or the surgery to correct the heart disease.

infants with cyanotic congenital heart disease undergoing surgery in the neonatal period have a high rate of brain injury resulting in seizures, stroke, cerebral palsy, and neurodevelopmental delays. neuroimaging abnormalities are found in 30% to 60% of cases and neurodevelopmental impairments occur in more than half of these children. the mechanisms of brain injury in these children are not fully understood. experimental animal models have shown that the abundant release of glutamate in the brain during hypoxic-ischemic insult results in brain injury. blocking glutamate receptors by administration of the anticonvulsant topiramate has been shown to prevent such injury in animal studies. this study is an open pilot trial of peri-operative topiramate administration to infants with cyanotic congenital heart disease to test the feasibility of this approach and generate preliminary data about markers of brain injury (serum s100b levels and urine metabolomics) and neurodevelopment at 18 months of age. if the approach is feasible and the preliminary data are encouraging a larger efficacy trial will be designed. although topiramate has been used in neonates and infants to treat seizures and in a pilot study in term infants with hypoxic-ischemic encephalopathy, this is the first study of its effects on markers of brain injury and neurologic outcomes in infants with cyanotic congenital heart disease.

Eligibility criteria:
inclusion criteria: * age less than 2 months * cyanotic congenital heart disease requiring surgery exclusion criteria: * genetic syndromes with high risk of neurodevelopmental delay * gestational age less than 35 weeks at birth * multiple organ failure or multiple organ anomalies

Keywords: brain injury stroke cerebral palsy seizures
evaluation of the impact of a call center in management of metastatic and/or advanced renal cell carcinoma patients treated with sunitinib (sutent) in first line

Conditions: Metastatic/Advanced Renal Cell Carcinoma

Summary: 100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (sutent) will be inclued and followed with standard care plus a call center principal assumption : the proportion of patients presenting with at least one grade 3 or 4 ae (whether related to sunitinib or not).

renacall is a prospective intermediate care study whose main aim is to evaluate the impact of a therapy management platform on the management of patients suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with sutent®. 100 mrcc patients treated receiving first line sutent® treatment shall be included in the study, and shall benefit both from conventional follow-up and from additional therapy management platform-based follow-up. platform follow-up shall consist in regular phone calls to accompany patients in their real life home management of their treatment with sunitinib (prevention, advice and guidance of patients towards options)..

Eligibility criteria:
inclusion criteria: man or woman aged 18 or over; * patient suffering from a/mrcc, receiving sunitinib first-line treatment, as per spc recommendations; * resolution (grade ≤ 1 according to ctcae version 4.03 of june 2010) of all acute toxic effects due to radiotherapy or surgical procedure prior to initiation of sunitinib; * patient who can be monitored for 6 months. * female patient of child-bearing age using a form of contraception during treatment with sunitinib and for at least 28 days after termination of treatment with sunitinib; * patient having signed his/her consent form; * patient affiliated with a social security scheme. non-inclusion criteria * patient participating in a clinical trial during sunitinib treatment; * patient managed by a home hospitalisation service during sunitinib treatment; * patient taking part in therapeutic education programmes, or benefiting from nursing consultation, or from any other significant treatment support and likely to impact adverse event management. * patient untreated and/or symptomatic brain metastases prior to sunitinib initiation; * patient refusing the use of his/her personal data. * patient with an ecog performance status upon inclusion \> 2; * patient presenting with a serum creatinine level \>1.5 times the upper limit of the normal level; * patient presenting with a bilirubin level \> 2 mg/dl, aspartate transaminase (asat) or alanine transaminase (alat) \>2.5 times the upper limit of the normal value, or \>5 times the upper limit of the normal value in the presence of liver metastases upon initiation of sunitinib treatment. * patients who are staff members of a centre involved in the study, or close to one of the staff members of a centre directly involved in conducting the study, or patients employed by pfizer and involved in conducting the study

Keywords: sunitinib call center management of patients nurses metastatic renal carcinoma
effect of acu-transcutaneous electrical nerve stimulation (tens) on post-exercise expiratory flow rate in subjects with asthma

Conditions: Asthma

Summary: the objective of this study is to investigate the effectiveness of acu-tens (transcutaneous electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate and exercise performance on the subjects with exercise.


Eligibility criteria:
inclusion criteria: * clinical diagnosis with asthma attending regular follow up at respiratory clinic exclusion criteria: * allergic to gel * suffered from other neurological or cardiovascular or musculoskeletal disorders that may affect their exercise performance * suffered from upper respiratory tract infection prior to the study

Keywords: asthma exercise training tens acupuncture fev1